Terumo Ultrasonic Air Sensor Recall Due to Backwards Crimped Wire
Terumo is recalling three Ultrasonic Air Sensors because a crimped wire was installed backwards, potentially causing false air bubble alarms during extracorporeal procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used during extracorporeal procedures where a defect may cause false alarms, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling three units of the Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785. The affected units have UDI 00886799000045 and serial numbers 20230, 20263, and 20265. These sensors are intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
The recall was initiated after internal testing at the supplier revealed that a crimped wire was placed into the air bubble detector sensor connector backwards. This installation error prevents the crimped wire from locking into the mating wire connector, resulting in an intermittent connection. This defect may cause false air bubble alarms.
The affected products were distributed worldwide and nationwide in the United States. Users of these devices should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall.
The recalled product
- Product
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 00886799000045
- Serial Numbers: 20230 20263 20265
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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